Sudden Cardiac DeathNCT01262508
Development of Algorithms to Predict Hemodynamic Instability
An observational study of Sudden Cardiac Death, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients being at risk of sudden cardiac death
Who may be able to join
- hospitalization
- Age > 17 years
Who cannot join
- documented diseases of the central nervous system
- impairment of mental health
- age > 85 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Development of Algorithms to Detect and Predict Hemodynamic Instability in Patients at Risk
Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.
Read the detailed description
70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing.
Autonomic reflex testing:
- Heart Rate Characteristics
- Heart Rate Variability
- Heart Rate Turbulence
- Blood Pressure Variability
- Baroreflex Sensitivity
- Hyperoxic Chemoreflex Sensitivity
Hemodynamic Monitoring:
- Heart Rate Trends
- Blood Pressure Trends
- Pulse Wave Characteristics
- Cardiac Output
- Peripheral Vascular Resistance
- Context information
- Conditions
- Sudden Cardiac Death
- Keywords
- autonomic nervous system
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risk Population | Patients being suspected to be at risk of hemodynamic instability due to medical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Dysfunction
Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing
Measured: 24 hours
Secondary outcomes (1)
Hemodynamic Deterioration
Acute hemodynamic changes (Blood pressure changes > 10 mm Hg, heart rate changes > 5 bpm both within 30 seconds) of a patient as assessed by hemodynamic monitoring
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Meyer, MD, Study chair, University of DuesseldorfMalte Kelm, MD, PhD, Study director, University of Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262508
- Sponsor's protocol ID
- Autonomics - Prediction
- Status last verified
- Feb 2016
- First submitted
- 16 Dec 2010
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jungen C, Zeus T, Balzer J, Eickholt C, Petersen M, Kehmeier E, Veulemans V, Kelm M, Willems S, Meyer C. Left Atrial Appendage Closure Guided by Integrated Echocardiography and Fluoroscopy Imaging Reduces Radiation Exposure. PLoS One. 2015 Oct 14;10(10):e0140386. doi: 10.1371/journal.pone.0140386. eCollection 2015.
PubMed 26465747Drexel T, Eickholt C, Muhlsteff J, Ritz A, Siekiera M, Kirmanoglou K, Schulze V, Shin DI, Balzer J, Rassaf T, Kelm M, Meyer C. Vagal heart rate control in patients with atrial fibrillation: impact of tonic activation of peripheral chemosensory function in heart failure. Adv Exp Med Biol. 2013;755:287-97. doi: 10.1007/978-94-007-4546-9_37.
PubMed 22826079
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Algorithms to Detect and Predict Hemodynamic Instability in Patients at Risk
- ClinicalTrials.gov ID
- NCT01262508
- Acronym / sponsor ID
- Autonomics - Prediction
- Conditions
- Sudden Cardiac Death
- Keywords
- autonomic nervous system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.
Detailed description
70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing.
Autonomic reflex testing:
- Heart Rate Characteristics
- Heart Rate Variability
- Heart Rate Turbulence
- Blood Pressure Variability
- Baroreflex Sensitivity
- Hyperoxic Chemoreflex Sensitivity
Hemodynamic Monitoring:
- Heart Rate Trends
- Blood Pressure Trends
- Pulse Wave Characteristics
- Cardiac Output
- Peripheral Vascular Resistance
- Context information
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk Population | – | –Patients being suspected to be at risk of hemodynamic instability due to medical history |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being at risk of sudden cardiac death
Key inclusion criteria (2 listed)
- hospitalization
- Age > 17 years
Key exclusion criteria (3 listed)
- documented diseases of the central nervous system
- impairment of mental health
- age > 85 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autonomic Dysfunction
Time frame: 24 hours
Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing
1 secondary outcome
Hemodynamic Deterioration
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Derived from this study: PubMed 26465747Jungen C, Zeus T, Balzer J, Eickholt C, Petersen M, Kehmeier E, Veulemans V, Kelm M, Willems S, Meyer C. Left Atrial Appendage Closure Guided by Integrated Echocardiography and Fluoroscopy Imaging Reduces Radiation Exposure. PLoS One. 2015 Oct 14;10(10):e0140386. doi: 10.1371/journal.pone.0140386. eCollection 2015.
- Derived from this study: PubMed 22826079Drexel T, Eickholt C, Muhlsteff J, Ritz A, Siekiera M, Kirmanoglou K, Schulze V, Shin DI, Balzer J, Rassaf T, Kelm M, Meyer C. Vagal heart rate control in patients with atrial fibrillation: impact of tonic activation of peripheral chemosensory function in heart failure. Adv Exp Med Biol. 2013;755:287-97. doi: 10.1007/978-94-007-4546-9_37.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Meyer, MD study chair
University of Duesseldorf
Malte Kelm, MD, PhD study director
University of Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Dysfunction (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.